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Optimal Timing of Coronary Intervention in Unstable Angina.


- candidate number1766
- NTR NumberNTR458
- ISRCTNISRCTN80874637
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR16-okt-2005
- Secondary IDsN/A 
- Public TitleOptimal Timing of Coronary Intervention in Unstable Angina.
- Scientific TitleA randomized clinical trial examining the outcome of immediate versus early (24 to 48 hours) percutaneous coronary intervention in patients with an acute coronary syndrome without persistent ST-segment elevation.
- ACRONYMOPTIMA
- hypothesisImmediate PCI in patients with NSTE-ACS is superior to early PCI with respect to 30-day size and occurrence of (non STE) myocardial infarction, death and revascularization.
- Healt Condition(s) or Problem(s) studiedNon ST-Elevation Acute Coronary Syndrome (NSTE-ACS)
- Inclusion criteria1. Age > 21 years; 2. Typical chest pain for angina pectoris lasting at least 10 minutes, within last 6 hours; 3. No contra-indication to PCI; And at least one of the following criteria: 1. 1 mm of horizontal or downsloping ST depression; 2. Dynamic ST- or T- wave changes > 1 mm in two contiguous leads; 3. Elevated troponin or CK-Mb; 4. Known coronary artery disease; 5. Two of following risk factors: DM, known hypertension, current smoking, family hx, hypercholesterolaemia, peripheral artery disease, age over 60 years.
- Exclusion criteria1. Chest pain suspected not to be caused by CAD; 2. Acute myocardial infarction requiring reperfusion therapy; 3. Thrombolytic therapy <24 hours / indication for trombolytic therapy; 4. Recent PCI (<14 days); 5. Thrombopenia (<100*1012/mm3); 6. Severe bleeding < 6 weeks; 7. Major surgery < 6 weeks; 8. Cerebral haemorrhage in medical history; 9. High blood pressure left untreated;(diastolic > 100 mmHg, systolic > 180 mmHg); 10. Life expectancy < 1 year due to co morbidity; 11. Known intracranial malformation or -neoplasm; 12. Participation in other study possibly interfering with the endpoints; 13. Inability to follow up; 14. Culprit lesion is a restenotic lesion.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jan-2008
- Target number of participants600
- InterventionsPatients admitted with NSTE-ACS who are eligible for PCI with stent implantation (as noted after angiography) will be randomised into one of the following treatment arms in this trial: 1. Immediate PCI; 2. Early PCI (<48 hours after admission, but after 24 hours). All patients will receive drug eluting stents and platelet IIb/IIIa blockers to at least 12 hours after PCI will be administered.
- Primary outcomeComposite incidence of death, MI and revascularization up to 30 days post enrolment.
- Secondary outcome1. Size of MI during initial hospitalization, quantified as peak CK-MB (mass), cumulative positive CK-Mb's; 2. 6 month angiographic restenosis as a composite endpoint with, “large” MI and death; 3. Incidence of individual and composite endpoints at 30 days and 6 and 12 months including recurrent NSTE-ACS; 4. Any revascularisation and/or restenosis (TVR) up to 6 months; 5. Re-hospitalisation because of coronary artery disease (CAD); 6. Incidence of major haemorrhage up to 30 days; 7. Hospital costs.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Robert K. Riezebos
- CONTACT for SCIENTIFIC QUERIES Robert K. Riezebos
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG), Department of Interventional Cardiology (ADIC)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Heart Foundation (NHS, Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryThis study is a randomised and prospective open-label multicenter trial in patients admitted with NSTE-ACS eligible for PCI. Approximately 600 patients admitted with NSTE-ACS and coronary anatomy suitable for PCI with stent-implantation will be randomized. Informed consent will be obtained from all patients meeting the inclusion criteria before the initiation of any study-specific procedures. After informed consent, coronary angiography will be performed directly after presentation to assess suitable coronary anatomy for PCI with stent implantation of the lesion/lesions that attributed to the presentation (culprit lesion). When found suitable, patients will be randomized using a computerized algorithm, to immediate PCI or early PCI. All patients will receive an infusion of platelet IIb/IIIa inhibitors during PCI until 12 hours after the procedure. PCI, including adjunctive therapies, will be performed according to standard institutional practices. Stent implantation is mandatory in all patients. All patients will be followed from randomisation through to hospital discharge, with respect to any clinically significant events (death, MI, revascularisation, or major haemorrhage). Three visits assessing MI (with ECG) and revascularisation procedures will be conducted at 30 days, 6 months and 12 months. The primary endpoint assessments are at 30 days. The total expected duration of a patients participation in this trial is approximately 12 months.
- Main changes (audit trail)
- RECORD16-okt-2005 - 7-mrt-2006


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